Global Regulatory Toxicology Expert
1 day ago
About the Role
We are seeking an experienced and inquisitive scientist with a strong digital skill set to join our team as a Senior Regulatory Toxicologist. This one-year temporary position is based in Denmark, and you will be part of our versatile team operating in a challenging and ever-evolving environment.
Key Responsibilities
- You will prepare toxicological risk assessments of drug product and process-related impurities, evaluating extractables & leachables from production equipment and primary packaging materials while maintaining a balance between regulatory requirements and scientific rigor.
- Engage in toxicological assessment and communication of environmental and occupational safety of drug candidates for production facilities, along with biological evaluation of devices.
- Leverage literature data, in silico models, in-vitro models, and biological testing to conduct toxicological safety assessments, overseeing studies conducted at internal or external laboratories or by in-silico consultants.
- Contribute to process improvements and the implementation of digital solutions.
Qualifications
- A master's degree or PhD in chemical/biochemical, life sciences, or a related field, coupled with a solid understanding of toxicology.
- At least 3 years of experience in toxicological risk assessment, with a strong familiarity of guidelines and regulations, including ICHM7, ICHQ3C, and ICHQ3D.
- Proficiency in in-silico evaluations and experimental work, either through direct involvement or collaboration with contract research organizations.
- The ability to manage multiple tasks, diverse stakeholders, and tight deadlines without compromising on quality.
- An innovative mindset, coupled with a keen interest in exploring digital solutions and driving process enhancements.
About Our Team
Join our dynamic Toxicology Development Projects department, which collaborates closely with our sister department as a Toxicology Centre of Excellence. We are responsible for the non-clinical safety assessment of drug development candidates. Our area is characterized by an open, sharing, collaborative, and ambitious atmosphere, offering ample opportunities for professional growth and development.
Benefits and Salary
This role offers a competitive salary, estimated around €90,000 - €110,000 per year, depending on qualifications and experience. Additionally, you can expect a range of benefits, including health insurance, pension scheme, and opportunities for professional development.
Contact Information
Please note that interviews will start in January 2025. You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.
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